Mobile Health Application to Improve HIV Medication Adherence

 描述（由申请人提供）：有超过一百万美国人感染艾滋病毒。高效的抗逆转录病毒疗法（ART）使艾滋病毒感染者（PLWH）能够拥有更长、更健康的生命。尽管治疗取得了进展，但只有四分之一的PLWH成功地控制了病毒。药物不依从是病毒抑制失败的重要原因。因此，制定了针对坚持的干预措施，大多数干预措施在短期内取得了一定程度的成功。然而，这些干预措施的影响通常不会随着时间的推移而持续，在大多数艾滋病毒治疗环境中提供更密集的依从性干预措施是不可行的。因此，人们对开发有效的电子交付干预措施很感兴趣。这项工作仍处于起步阶段，而且很少有工作已经完成。 已经完成，以建立移动的健康ART依从性应用程序的功效。一个移动的健康应用程序将最大限度地提高干预的便携性，并允许实时遵守跟踪和反馈，并随时访问内容或服务，以提高遵守。本提案旨在开发和完善移动的健康ART依从性应用程序，并进行初步随机对照试验（RCT），比较面对面ART依从性干预和随后的移动的健康ART依从性应用程序（mARTAA）与单独面对面依从性干预（接近标准治疗（SOC））。这一系列研究的长期目标是传播一种有效的、移动的健康ART依从性应用，该应用可以很容易地集成到临床护理中。在拟议研究的第1阶段，我们将根据从试点参与者（n=20）收集的数据，使用试点和修改的迭代过程开发和完善mARTAA。第2阶段（n=60）将包括一项比较mARTAA和SOC的初步RCT。RCT中的参与者将完成基线访谈和1、3、6和12个月的随访访谈。主要结局变量将是基于电子药盒数据的ART依从性。我们期望，作为该项目的结果，我们将开发并证明移动的健康应用程序的有效性，以提高ART依从性，该应用程序可以很容易地传播到现实世界的临床环境中。这种干预措施有望改善艾滋病毒的抑制，减缓疾病进展，减少与艾滋病毒有关的发病率和死亡率，降低其他人感染艾滋病毒的风险，并尽量减少艾滋病毒耐药株的产生。

 DESCRIPTION (provided by applicant): There are more than a million Americans who are infected with HIV. Highly effective antiretroviral therapy (ART) makes it possible for persons living with HIV (PLWH) to have longer, healthier lives. Despite treatment advances, only a quarter of PLWH successfully keep the virus under control. Medication non-adherence is a significant contributor to unsuccessful viral suppression. As a result, interventions targeting adherence have been developed, with most interventions demonstrating some degree of success in the short-term. However, the impact of these interventions is generally not sustained over time, and it is not feasible to deliver more intensive adherence interventions in most HIV treatment settings. As a result, there has been interest in developing efficacious electronically-delivered interventions. This work is still in its infancy, and there is a paucity of work that has been done to establish the efficacy of mobile health ART adherence applications. A mobile health application would maximize the portability of the intervention and allow for real-time adherence tracking and feedback and ready access to content or services to enhance adherence. The present proposal aims to develop and refine a mobile health ART adherence application and to conduct a preliminary randomized controlled trial (RCT) comparing a face-to-face ART adherence intervention followed by the mobile health ART adherence application (mARTAA) to the face-to-face adherence intervention alone, which approximates standard-of-care (SOC). The long-term goal of this line of research is to disseminate an efficacious, mobile health ART adherence application that can be integrated readily into clinical care. In Phase 1 of the proposed study, we will develop and refine mARTAA using an iterative process of piloting and modification based on data collected from pilot participants (n=20). Phase 2 (n=60) will consist of a preliminary RCT comparing mARTAA and SOC. Participants in the RCT will complete a baseline interview and follow-up interviews at 1, 3, 6, and 12 months. The primary outcome variable will be ART adherence based on electronic pill box data. We expect that, as a result of this project, we will have developed and demonstrated the efficacy of a mobile health application to improve ART adherence that can be disseminated easily into real-world clinical settings. Such an intervention holds the promise of improving HIV viral suppression, slowing disease progression, reducing HIV-related morbidity and mortality, decreasing the risk of HIV infection in others, and minimizing the production of treatment resistant strains of HIV.